admin – eisai china lnc.-威尼斯人888

 admin – eisai china lnc.-威尼斯人888

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eisai and biogen announced today that eisai has initiated the rolling submission of a biologics license application (bla) to the u.s. food and drug administration (fda) for lecanemab-irmb (u.s. brand name: leqembi®) subcutaneous autoinjector for weekly maintenance dosing after it was granted fast track designation by the fda.

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eisai co., ltd. announced on jan 26 that it has submitted a new drug applicationfor ultrahigh-dose mecobalamin (development code: e0302) for the indication of amyotrophic lateral sclerosis (als) to the pharmaceuticals and medical devices agency in japan.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has submitted a marketing authorization application in japan for its in-house discovered fibroblast growth factor (fgf) receptor (fgfr1, fgfr2, fgfr3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: e7090, “tasurgratinib”) for biliary tract cancer with fgfr2 gene fusion. in japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with fgfr2 gene fusion by the ministry of health, labour and welfare, (mhlw). under this system, this application will be subject to priority review.

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